RecruitingPhase 3NCT06056830

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Sponsor

Clarity Pharmaceuticals Ltd

Enrollment

383 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Prostatic Neoplasms

Summary

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new PET/CT imaging scan using a radioactive tracer (64Cu-SAR-bisPSMA) that targets prostate-specific membrane antigen (PSMA) — a protein highly expressed in prostate cancer — to better detect where high-risk prostate cancer has spread before surgery. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with high-risk prostate cancer (confirmed by biopsy) and have not yet had any treatment - High-risk is defined by clinical staging of T3a or higher, Gleason grade group 4 or 5, or PSA above 20 - You are planning to have radical prostatectomy (surgical removal of the prostate) with lymph node dissection **You may NOT be eligible if...** - You have had a recent high-energy radioactive scan within the required washout period - You have a known allergy to the imaging tracer or its components - Your prostate cancer is predominantly small cell or neuroendocrine type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG64Cu-SAR-bisPSMA

All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Locations(27)

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Mayo Clinic- Phoenix

Phoenix, Arizona, United States

Urology Group of Southern California

Los Angeles, California, United States

Greater Los Angeles VA Medical Center

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

Mayo Clinic- Jacksonville

Jacksonville, Florida, United States

Biogenix Molecular, LLC

Miami, Florida, United States

NorthShore University Health System, Glenbrook Hospital

Glenview, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

BAMF Health

Grand Rapids, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Mayo Clinic- Rochester

Rochester, Minnesota, United States

XCancer Omaha LLC

Omaha, Nebraska, United States

Mount Sinai Doctors Urology Faculty Practice

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Urologic Specialists

Tulsa, Oklahoma, United States

Oregon Urology

Springfield, Oregon, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Associates of Nashville

Nashville, Tennessee, United States

Urology Clinics of North Texas

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The Urology Place

San Antonio, Texas, United States

Intermountain Health

Murray, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

St. Vincent's Sydney

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06056830

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